U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) is part of the Department of Health and Human Services (HHS). The FDA consists of centers and offices which regulate human and veterinary drugs, biological products, medical devices, the food supply, cosmetics and radiation emitting products. [1]

Government funded vivisection

Government funded animal testing spends billions of dollars every year and kills millions of animals in an essentially unregulated industry. Hundreds of institutions and thousands of individuals profit off vivisection. Furthermore, the government pays for the same experiments to be done over and over. In the fiscal year ending in 2005, seven government agencies funded over 28,937 projects for experiments on 27 species, including: monkeys, dogs, cats and rodents. These included: 1200 separate projects (at up to $495,600,000) examining drug addiction. 778 projects studying "neural information processing" in 11 species racked up approximately $321,314,000. No experiment, however ridiculous, useless or painful; is illegal. The majority of animals used in experimentation receive absolutely no protection under current laws. Government funded animal testing costs U.S. taxpayers over $12 billion annually.[2] See also U.S. Government's War on Animals, section 5.

FDA testing requirements

Prescription for Disaster with Gary Null, PhD. - 2006

The FDA requires massive amounts of animal testing for the marketing of industrial chemicals, vaccines, and drugs.

For example, companies marketing fluoride products swab the teeth of 200 rats with the test substance for two weeks. The animals are subsequently killed and their heads baked in an oven for an hour. [3]

The FDA is responsible for ensuring the safety, effectiveness, and quality of pharmaceuticals, biologicals, and medical devices intended for human use. Also the safety, efficacy and quality of pharmaceuticals for animals, food, cosmetics and radiation emitting products. Thousands of rats, mice, rabbits, dogs, and primates are killed in "pre-clinical" tests to for new drugs (including all ingredients and even minor differences in formulas). Following an extensive battery of animal testing, drugs generally undergo three phases of clinical trials. The fact that months or years of human studies are also required suggests health authorities do not trust the results. [4]In 2004, the FDA reported that 92 out of every 100 drugs that successfully pass animal trials, subsequently fail human trials.[5], [6] See also animal testing, section 3 on product testing.

Food, Drug & Cosmetic Act

The Federal Food, Drug, and Cosmetic Act (FD&C Act) [7] does not specifically require the use of animals in testing cosmetics for safety, nor subject cosmetics to FDA premarket approval. [8] For current lists of U.S., Canadian and international companies which do not test on animals, visit the Coalition for Consumer Information on Cosmetics. [9]

Pharmaceuticals & vaccine issues

FDA animal testing

Facility information, progress reports & USDA-APHIS reports

For links to copies of a facility's U.S. Department of Agriculture (USDA)-Animal Plant Health Inspection (APHIS) reports, other information and links, see also Stop Animal Experimentation Now!: Facility Reports and Information. This site contains listings for all 50 states, links to biomedical research facilities in that state and PDF copies of government documents where facilities must report their animal usage. (Search: FDA, Rockville, Maryland; FDA National Center for Toxicological Research, Jefferson, Arkansas; FDA/ N.C.T.R., Jefferson, Arkansas.)

USDA AWA reports

As of May 26, 2009, the USDA began posting all inspection reports for animal breeders, dealers, exhibitors, handlers, research facilities and animal carriers by state. See also USDA Animal Welfare Inspection Reports.

Farm animal, meat & dairy issues

Waste products fed to farm animals

The FDA finally banned the practice of feeding cow meat and bone meal back to cows in 1997 (after the Mad cow disease epidemic in Great Britain). However, dried poultry waste and sewage sludge are routinely fed to cattle. Pigs and chickens are still routinely fed the bones, brains, meat scraps, feathers, and feces of their own species. Furthermore, tens of millions of shelter animals are also picked up by rendering plants. Thus commercial meat, dairy, and egg products often come from animals whose diet included the ground up remains of cats and dogs, including the euthanasia drugs injected into their bodies. [10] 40 billion pounds a year of slaughterhouse wastes (blood, bone, viscera) and euthanized cats and dogs from veterinarians and animal shelters, are rendered annually into livestock feed. [11] Moreover, the FDA has been using inaccurate, incomplete, and unreliable data to track and oversee feed ban compliance. [12], [13] See also USDA.

Hormones

Bovine growth hormones (rBGH)

Dairy cows on rBGH

The FDA approved the use of recombinant bovine growth hormone (rbGH) being injected into cows on February 4th, 1994. Both Europe and Canada turned down Monsanto's application for approval. Developed and manufactured by the Monsanto, this genetically engineered hormone forces cows to artificially increase milk production by 10 to 15%. [15] Monsanto spent approximately half a billion dollars on a hormone to increase milk production (for an already glutted, taxpayer-subsidized market). Additionally, Posilac creates additional Growth Factor One (IGF-1) in milk (a growth hormone which is identical in cows and humans). IGF-1 is considered to be a fuel cell for cancer growth and has been identified in the rapid growth cancer. The FDA insists that IGF-1 is destroyed in the stomach. [16] However, if that were true, the FDA has proven that breast feeding cannot work. [17] It is worth noting that rBGH is banned in every industrialized country in the world except for the U.S., Mexico and Brazil. According to Dr. Michael Hanson of the Consumers Union of the U.S., there is strong scientific evidence to support potential health hazards of rBGH and a case for labeling dairy products that contain rBGH. [18]

The need for such for an increase in milk production has been questioned since the dairy industry has been overproducing for 60 years. Between 1986 and 1987, under the Dairy Termination Program, dairy farmers were paid over 1.3 billion dollars to slaughter their cows. 144 dairy producers received over one million apiece to refrain from dairy farming for five years and one California producer received 20 million dollars. However, according to the General Accounting Office (GAO), "Total milk production did not decrease because nonparticipating farmers increased their production". [19] Additionally, cows injected with rBGH also have a 25% increase in udder infections and a 50% increase in lameness. [20] In August 2008, Monsanto sold their Posilac division to Eli Lilly.[21] See also meat & dairy industry, section 4.

EU ban on hormones & imports from U.S./Canada

Since 1995, the European Union (EU) has prohibited the treatment of any farm animals with sex hormones, which includes a ban on hormone treated meat from the U.S. and Canada. [22] See also European Union, section 9.

Crop & biotechnology issues

Soy health labeling & GMOs

Lester Crawford was the acting commissioner credited with the biggest boom in soy history. During the Crawford/ Jane Henney 1999 tenure, the FDA approved heart health claims for soy and soya foods. (Genetically modified soy is labeled soya in the EU). From 2001 to 2004, U.S. food manufacturers introduced over 1,600 new foods with soy as an ingredient, averaging 400 new products per year. According to the Mintel’s Global New Products Database, there were 460 new products in 2001, 321 in 2002, 386 in 2003 and 443 in 2004. Between 1992 and 2003, soy food sales had a 15% annual growth rate, increasing from $300 million to $3.9 billion over 11 years. As new categories have been introduced, soy has been repositioned in the market place. New customers select soy for both health and philosophical reasons.[23]

GMO (genetically modefied organism) soy beans are altered to enable plants to withstand weedkillers, particularly Monsanto's Roundup. The FDA tripled the allowable limit for residues of Roundup's active ingredients on harvested crops. Many scientists protested allowing increased residues to support the biotechnology industry. Even after Monsanto's own research raised safety concerns for Roundup Ready soybeans, the FDA did not call for further testing. Half the soybeans grown in the U.S. are Roundup Ready. According to Monsanto, they contain 29% less of the brain nutrient choline and 27% more trypsin inhibitor, a potential allergen. Soy is often prescribed and consumed for its phytoestrogen content; however, GMO soy beans have lower levels of phenylalanine, an essential amino acid that affects levels of phytoestrogens. Lectin levels, the usual culprit in soy allergies, are nearly double in GMO soybeans. [24]

Global GMO & herbicide market

The top biotechnology companies are Monsanto, DuPont, Syngenta and Bayer. (Syngenta is a subsidiary of parent companies AstraZeneca and Novartis. Aventis' agribusiness division was bought out by Bayer.) They account for almost 100% of the genetically engineered seed and 60% of the global pesticide market. Thanks to recent acquisitions, they now own 23% of the commercial seed market. In 1999, almost 80% of total global transgenic acreage was planted in GMO soy, corn, cotton and canola. Until then, farmers could spray herbicides before planting, but not after, as herbicides would kill the intended crop. The other 20% of genetically modified acreage is planted with crops that produce pesticides. Monsanto’s "New Leaf" potato kills potato beetles, but is itself registered as a pesticide with the Environmental Protection Agency (EPA). The five largest biotech companies in the world are also the five largest herbicide companies. GMOs ensure a continuous and ever-expanding market for their agrochemicals. [25]

Under current policy, the government provides large subsidies to farmers to produce grains, in particularly corn and soybeans. Livestock producers use corn and soy as a base for animal feed as they are protein rich and fatten up the animals. They are also cheap (due to government subsidies.) Livestock consumes 47% of the soy and 60% of the corn produced in the US. [26]

Leadership

FDA Commissioners: 1998 to present

Jane Henney served as Commissioner of the FDA from December 1998 until the newly-inaugurated President George W. Bush asked for her resignation in January 2001. [27] Dr. Henney was the Director of the CIGNA Corporation between 2004 and 2007. She has also been Director of AmerisourceBergen and AstraZeneca, PLC. Dr. Henney was the VP of Health Affairs at the University of Cincinnati Medical Center and a Sr. Scholar at the Association of Academic Health Centers, until 2003.

The chief position at the FDA remained vacant until the confirmation of Mark McClellan in November 2002. McClellan left the FDA in March 2004 to head the Centers for Medicare and Medicaid Services. President Bush then appointed FDA acting commissioner and longtime deputy commissioner Lester Crawford in February of 2005. [28] He was confirmed in July of 2005. After Dr. Crawford's abrubt resignation on September 26, 2005; Andrew von Eschenbach was appointed as acting commissioner. [29] von Eschenbach was nominated in March 2006 and confirmed as the FDA Commissioner in December 2006.

In June of 2009, Dr. Joshua M. Sharfstein was appointed by President Obama as FDA Commissioner. He had served as the Acting Commissioner between March and May of 2009. [30]Margaret Hamburg, MD became the 21st Commissioner on May 18, 2009.[31]

Former FDA Chief pleads guilty in stock case

In October of 2006, Lester Crawford pleaded guilty to conflicts of interest and false reporting of stocks he owned in companies he was in charge of regulating. He had "abruptly resigned" in September of 2005, after admitting to filing false financial reports. Beginning in 2002, Dr Crawford filed seven false reports with a government ethics office and Congress. As deputy, then commissioner and later commissioner of the FDA, he oversaw product regulations accounting for approximately 25 cents of every dollar spent by U.S. consumers. Dr. Crawford earned nearly $42,000 in dividends from illegally held shares while at FDA. Nearly $29,000 came from FDA regulated Embrex Inc., where he was the director. He and Mrs. Crawford also owned between $188,000 and $336,000 in shares for Pepsico, Sysco, Kimberly-Clark and Wal-Mart; all of which are "significantly regulated" by the FDA. [32]

"Food Safety Czar"

On May 1, 2007, Dr. David W.K. Acheson, a former University of Maryland Medical School professor and previously the chief medical officer in charge of FDA food safety; was appointed to a newly created position of "Food Safety Czar" by President Bush. Dr. Acheson was directed "to develop a plan for addressing shortcomings exposed by recent scares in the human food supply."

"The appointment came just before the House Oversight and Government Reform Committee held a hearing on the challenges facing the FDA, including protecting the food supply, that was attended by three former agency commissioners. Dr. David A. Kessler, FDA commissioner under former Presidents George Bush and Bill Clinton, called the food safety system 'broken' and said the FDA needs to restore research and other efforts to prevent food borne illness." [33]

Lobbying

Since January of 2006, Lester Crawford has worked as a Sr. Counsel for Policy Directions Inc.[34] Policy Directions is a Washington, DC based public relations and lobbying firm for the animal testing, animal breeding, pharmaceutical, agribusiness, biotechnology and processed food industries, as well as universities and institutions receiving government grants for animal research. [35], [36] Incredibly, Dr. Crawford's firm, is in the business of writing legislation for government regulatory agencies, among other things. Their list of accomplishments includes:

"Industry coalition draft of legislative authority for a regulatory agency" whose language was "included in the final bill."

Leading a "coalition" of universities, research institutions, pharmaceutical and biotechnology companies to lobby Congress against "costly and ineffective rule making."

Leading a "broad industry coalition" to stop several "negative amendments to agriculture/FDA appropriations bills".

Worked with legislators in supporting and drafting the "Best Pharmaceuticals for Children Act."

Achieved FDA support for a product that had originally been voted down.

Interceded on behalf of a client when the FDA final approval. ..Our client's product was approved in a timely manner.

Successfully lobbied Congress to secure a 20 million dollar, four year pilot program for our client's product.

Creating a coalition of six leading biotechnology firms to promote advantageous legislation and meeting with agency officials to prevent "onerous rule making."

Drafting an Op-ed on a "controversial research issue" which was printed in a regional paper. [37]

Funding fees from pharmaceutical industry

Regulators don't negotiate their budgets with industries they oversee, with the exception of the FDA. In the early 1990s, the pharmaceutical industry began paying the FDA millions of dollars in user fees in order to speed up the drug approval process. These fees "now fund more than half the agency's critical drug-review process." Industry groups and the FDA renegotiate the fees and how they're used every five years, giving drug makers "considerable input into which programs receive funding." In 2006 the FDA negotiated an agreement with the Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization. Industry groups pushed for even faster decisions on labeling and other "conditions" of new drugs and the FDA negotiated more funding to monitor drug safety following approval. [38]